MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4; RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number	07K65-29
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported falsely elevated architect free t4.The customer reported results over the upper limit and when repeated the results were within normal range.(customer reference range: free t4 reference range 0.7¿1.48).The customer further reported this also included a sample from a male patient not receiving thyroid treatment.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated architect free t4.The customer reported results over the upper limit and when repeated the results were within normal range.(customer reference range: free t4 reference range 0.7¿1.48).The customer further reported this also included a sample from a male patient not receiving thyroid treatment.There was no reported impact to patient management.Update: the customer provided further information on (b)(6) 2025: the customer reported that they incorrectly made the buffer solution without adding concentrated dilution buffer.The customer does not believe that the patient results issue and controls issue was due to an abbott device but rather the customer believes that this event was caused by the incorrectly made buffer solution.
Additional Manufacturer Narrative
Section b5 was updated with additional information.The customer does not believe that the patient results issue and controls issue was due to an abbott device but rather the customer believes that this event was caused by the incorrectly made buffer solution.Based upon this new information, this complaint is no longer a reportable event.

• Brand Name: ARCHITECT FREE T4
• Common Device Name: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 23662193
• Report Number: 3005094123-2025-00601
• Device Sequence Number: 13059742
• Product Code: CEC
• UDI-Device Identifier: 00380740119799
• UDI-Public: (01)00380740119799(17)260407(10)75463UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07K65-29
• Device Lot Number: 75463UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/11/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/18/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I2K PROC MOD, 03M74-01, (B)(6); ARC I2K PROC MOD, 03M74-01,(B)(6)
• Patient Sex: Unknown